The present invention relates to a connector assembly including an end portion for connection to a sterilisation container. The connector assembly includes a releasable connector port for releasably connecting said container assembly to a treatment station for multi-purpose treatment of goods, such as plugs, that is enclosed in said container.
The invention also relates to a multi-treatment sterilising system, including a multi-purpose container for treatment and storing of articles being enclosed there within. Finally, the invention relates to a method for transferring sterilised goods from a multi-purpose container using a system according to the invention.
When sterilising small articles, such as plugs or caps for pharmaceutical purposes, it is known to use a multi-purpose container, in which the articles are submitted to several different treatments such as washing; sterilising and drying. Rubber plugs are usually also siliconised, all within the same multi-purpose container. Siliconising is a procedure for providing the plugs with a thin layer of silicon oil, which makes the introduction of the plugs into pharmaceutical test tubes easier.
After treating the goods in the container, it is desirable to store said container in a manner such that the risk for contamination of the sterilised goods is eliminated. In order to achieve this, the container is pressurised before storing so that the internal pressure of the container is greater than the ambient pressure.
After storing, the goods are to:r be transferred to suitable packages. This must be done in a sufficiently clean environment, such as a clean room or isolator. A problem occur however in keeping the environment clean when it is confronted with the container that has been stored under unclean conditions. To avoid this problem, the exterior of a port of the container has to be sterilised before transfer of the goods into the clean environment through said opening. The procedure for sterilising the port is however time-consuming and difficult to handle. There is also a risk that an un-sterilised port may be inserted into the clean room by mistake, since there is no way to immediately determine whether said port is clean or not.
The aim of this invention is to eliminate the above mentioned problems during transfer of the sterilised goods to a clean environment. The aim is also to provide a sterilising system where these problems do not occur, and which operates quickly and safely. Additionally, the aim is to provide a method using such a system.
The first of the above mentioned aims is reached by a connector assembly according to the introduction in which said connector assembly further includes a second port that is initially provided with a detachable rapid transfer port cap that corresponds to a rapid transfer port means in a transfer station. The connector port and the transfer port are in fluid connection via a goods stopper means. Said goods stopper means prevents the goods from passing through the connector port when said cap and said means are interconnected for transfer of the goods via the second port to the transfer station.
With goods stopper means we here refer to a means which stops goods from passing through it, but allow fluid to pass through. Such a means could for example be a perforated plate, even though many other designs are possible.
With rapid transfer port cap we do here refer to one of the double doors used in rapid transfer ports such as described in for example EP 0 586 307, SNE LA CALHENE. These kinds of ports consist of a rapid transfer port means, comprising a door and a doorframe that is to be arranged at a clean room wall. The door is inter-connectable with a rapid transfer port cap that seals a container containing the clean goods. When interlocking, one side of the rapid transfer port cap that has been directed outwards from the container and thus could have been contaminated during storing, is locked together with the outer side of the door of the rapid transfer port means. The xe2x80x9cdouble doorxe2x80x9d comprising the interlocked door and cap can then be opened, while substantially all contamination is safely held between the cap and the door.
According to the invention, there is a connector port assembly comprising one connector port for connection to a treatment station. This connector port can be designed as the ports used in prior art. There is also second port that initially is covered by a detachable transfer port cap. This port will later be used as a transfer port when the cap has been removed and the goods are to be transferred to a clean environment outside of the container. The use of a rapid transfer port thus eliminates the need of sterilising a port of the container for transfer of the sterilised goods.
Performing sterilisation of a port according to prior art takes about 30-40 minutes, while the interconnection and opening of the rapid transfer port takes only about 5-10 minutes. A connector assembly according to the invention thus makes the transfer procedure much more time efficient than the procedures according to prior art.
The function of the goods stopper means is as follows. When the container is connected to the treatment station via the connector port, the transfer port and thus the inside of the rapid transfer port cap will be sterilised as well as the goods inside of the container, since the goods stopper means provide fluid contact between the connector port, where the sterilising medium is supplied, and the rapid transfer port cap.
At a later stage, when the sterilised goods are to be transferred to a clean room for for example packaging, the container is directed so that the rapid transfer port cap is aligned essentially vertically. After removal of the transfer port cap, the goods will flow down through the rapid transfer port opening. Because of the stopper means, no articles will fall in to the dead end of the connector port.
Preferably, said rapid transfer port cap is arranged adjacent to the connector port. This will make the procedure when using and manufacturing the connector assembly considerably easier.
Said connector assembly could advantageously be essentially Y-shaped, with the connector port and the rapid transfer port cap being provided at the arms of the Y, respectively. The base of the Y-shaped connector assembly is constituted by an end portion for connection with the container. In such an embodiment, the different ports are easily handled, since changing between the ports can be made simply by rotation of the connector means and/or the container.
Preferably the connector assembly is provided at an end of the container, that is directed upwardly during treatment and downwards during transfer of the content in said container. During treatment, when the connector assembly is directed upwards, no liquids or fluids can be stored in the connector assembly. During transfer, the connector assembly, or at least the rapid port cap should be directed downwards to empty the container merely by help of gravity.
The connector assembly is advantagely provided with a sensor for detecting the presence of the rapid transfer port cap on said container. If the sensor shows that no rapid transfer port cap is present, the sterilisation process would not continue. The sensor provides thus an easy control device to ensure that the treatment process of the goods is performed properly.
The invention further relates to a multi-treatment sterilising system, including a multi-purpose container for treatment and storing of articles being enclosed there within, at least one treatment station, a transport means and a transfer station for transferring said objects into a clean area for further processing such as packing, and being characterised in said system including a connector assembly according to the invention, which assembly is arranged at the container.
Preferably said transfer station includes rapid transfer port means corresponding to the rapid transfer port cap of the connector assembly. The transfer station could also be provided with glove ports for manually interconnecting the rapid transfer port means and the rapid transfer port cap for detachment of said rapid transfer port cap from said container. The process of interconnecting the rapid transfer port cap with the rapid transfer port means to form the double port, which contains any eventual contamination, is so delicate with ports available today, that it can only be made by hand. Therefore, glove ports are necessary to allow manual interconnecting of the means and cap.
Advantageously, said transfer station can be provided with a feed pipe that is pivotably arranged to be movable from a position away from the container to a position extending through the opened rapid transfer port of the container. When the rapid transfer port is open, i. e. the cap and means are interconnected, there is still a small risk of contamination from the sides of the doorframe in which the door was initially disposed. To avoid spreading of this contamination to the sterilised goods, the feeding pipe can be inserted through the opening of the rapid transfer port and thus provide a clean outlet channel for the sterilised goods in the container.
Finally the invention also relates to a method for transferring sterilised goods from a multi-purpose container using a system according to the invention. The rapid transfer port cap of the connector assembly and the rapid transfer port means of the transfer station are then manually interconnected to remove said cap from the container, using glove ports for manually handling the means and cap.